Highlights
- •3-year event-free survival data in PrefHer were consistent with previous trials.
- •The overall safety profile during adjuvant treatment was as expected.
- •H SC was well tolerated and no new safety signals were identified.
Abstract
Aim
To assess efficacy (event-free survival, EFS) and safety in patients followed up for
3 years in the PrefHer study (NCT01401166).
Patients and methods
Post surgery and post chemotherapy in the (neo)adjuvant setting, patients with human
epidermal growth factor receptor 2 (HER2)-positive early breast cancer were randomised
to receive four cycles of the subcutaneous form of trastuzumab (Herceptin® SC [H SC] via single-use injection device [Cohort 1] or delivery via a hand-held
syringe from an SC Vial [Cohort 2]; 600 mg fixed dose) followed by four of the intravenous
form of trastuzumab (Herceptin® [H IV]; 8 mg/kg loading, 6 mg/kg maintenance doses) in the adjuvant setting or vice
versa every 3 weeks. Patients could have received H before randomisation. H was then
continued to complete a total of 18 cycles, including any cycles received before randomisation.
Results
A total of 488 patients were randomised across both cohorts. After median follow-up
of 36.1 months, 3-year EFS across both groups in the evaluable intention-to-treat
population (467 patients) was 90.6% overall, 89.9% in Cohort 1, and 91.1% in Cohort
2. No new safety signals were identified during long-term follow-up, with only one
cardiac serious adverse event in the safety population (483 patients).
Conclusions
Three-year EFS data following H SC and H IV treatment are consistent with those reported
by previous trials for H in the adjuvant setting. The overall safety profile during
adjuvant treatment was as expected.
Keywords
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Article info
Publication history
Published online: September 27, 2017
Accepted:
August 18,
2017
Received in revised form:
August 18,
2017
Received:
July 14,
2017
Identification
Copyright
© 2017 Elsevier Ltd. All rights reserved.
